A New Approach to Calculate EMEA’s Predicted Environmental Concentration for Human Pharmaceuticals in Groundwater at Bank Filtration Sites

Abstract

In recent years, human pharmaceutical substances have been increasingly detected in the aquatic environment. Specific attention has been drawn to the occurrence of pharmaceutical substances at bank filtration sites which are used for drinking water production. In the course of the authorisation application for new pharmaceutical compounds, an environmental risk assessment is required. Currently, the expected concentration of the human pharmaceutical compound in groundwater at bank filtration sites is calculated following the guideline Pre-Authorisation Evaluation of Medicines for Human Use issued by the European Medicines Agency (EMEA 2006). A simple estimation is applied: The predicted environmental concentration (PECGW) is the predicted environmental concentration in surface water (PECSW) multiplied with 0.25. A new approach considering the hydraulic and hydrogeological characteristics of bank filtration sites as well as transport processes is presented in this study. First, a numerical groundwater flow model was developed to simulate the groundwater flow processes at bank filtration sites in general. Flow times were calculated as a function of the hydraulic and hydrogeological parameters: hydraulic conductivity, shore-well distance, screen depth and extraction rate. In a second step, the PECGW was calculated based on the compound concentration in surface water and the modelled groundwater flow times considering linear sorption and first-order decay. Sorption and degradation can only be calculated based on the data provided by the pharmaceutical company in the course of the authorisation application. The current approach following the EMEA guideline invariably connects the PECGW with the PECSW without considering sorption and/or degradation processes. We introduce an approach that incorporates the hydraulic process bank filtration and the main transport processes sorption and degradation. The new approach is compound specific as well as aquifer, flow and transport specific resulting in a more realistic PECGW value compared to the old approach.